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Notice

Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc.

Document Details

Information about this document as published in the Federal Register.

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ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic class, and applicants Start Printed Page 23070therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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SUPPLEMENTARY INFORMATION:

The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix of subpart R.

In accordance with 21 CFR 1301.34(a), this is notice that on November 10, 2016, Galephar Pharmaceutical Research, Inc., #100 Carr 198, Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II.

The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes.

The import of this class of controlled substance will be granted only for analytical testing, research, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale.

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Dated: May 15, 2017.

Louis J. Milione,

Assistant Administrator.

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[FR Doc. 2017-10234 Filed 5-18-17; 8:45 am]

BILLING CODE 4410-09-P